Limited versus full sternotomy for aortic valve replacement

Copyright \ua9 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. BACKGROUND: Aortic valve disease is a common condition easily treatable with cardiac surgery. This is conventionally performed by opening the sternum (\u27median sternotomy\u27) and replacing the valve under cardiopulmonary bypass. Median sternotomy is well tolerated, but as less invasive options become available, the efficacy of limited incisions has been called into question. In particular, the effects of reducing the visibility and surgical access have raised safety concerns with regard to the placement of cannulae, venting of the heart, epicardial wire placement, and de-airing of the heart at the end of the procedure. These difficulties may increase operating times, affecting outcome. The benefits of smaller incisions are thought to include decreased pain; improved respiratory mechanics; reductions in wound infections, bleeding, and need for transfusion; shorter intensive care stay; better cosmesis; and a quicker return to normal activity. This is an update of a Cochrane review first published in 2017, with seven new studies. OBJECTIVES: To assess the effects of minimally invasive aortic valve replacement via a limited sternotomy versus conventional aortic valve replacement via median sternotomy in people with aortic valve disease requiring surgical replacement. SEARCH METHODS: We performed searches of CENTRAL, MEDLINE and Embase from inception to August 2021, with no language limitations. We also searched two clinical trials registries and manufacturers\u27 websites. We reviewed references of primary studies to identify any further studies of relevance. SELECTION CRITERIA: We included randomised controlled trials comparing aortic valve replacement via a median sternotomy versus aortic valve replacement via a limited sternotomy. We excluded trials that performed other minimally invasive incisions such as mini-thoracotomies, port access, transapical, transfemoral or robotic procedures. Although some well-conducted prospective and retrospective case-control and cohort studies exist, these were not included in this review. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial papers to extract data, assess quality, and identify risk of bias. A third review author provided arbitration where required. We determined the certainty of evidence using the GRADE methodology and summarised results of patient-relevant outcomes in a summary of findings table. MAIN RESULTS: The review included 14 trials with 1395 participants. Most studies had at least two domains at high risk of bias. We analysed 14 outcomes investigating the effects of minimally invasive limited upper hemi-sternotomy on aortic valve replacement as compared to surgery performed via full median sternotomy. Upper hemi-sternotomy may have little to no effect on mortality versus full median sternotomy (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.45 to 1.94; 10 studies, 985 participants; low-certainty evidence). Upper hemi-sternotomy for aortic valve replacement may increase cardiopulmonary bypass time slightly, although the evidence is very uncertain (mean difference (MD) 10.63 minutes, 95% CI 3.39 to 17.88; 10 studies, 1043 participants; very low-certainty evidence) and may increase aortic cross-clamp time slightly (MD 6.07 minutes, 95% CI 0.79 to 11.35; 12 studies, 1235 participants; very low-certainty evidence), although the evidence is very uncertain. Most studies had at least two domains at high risk of bias. Postoperative blood loss was probably lower in the upper hemi-sternotomy group (MD -153 mL, 95% CI -246 to -60; 8 studies, 767 participants; moderate-certainty evidence). Low-certainty evidence suggested that there may be no change in pain scores by upper hemi-sternotomy (standardised mean difference (SMD) -0.19, 95% CI -0.43 to 0.04; 5 studies, 649 participants). Upper hemi-sternotomy may result in little to no difference in quality of life (MD 0.03 higher, 95% CI 0 to 0.06 higher; 4 studies, 624 participants; low-certainty evidence). Two studies reporting index admission costs concluded that limited sternotomy may be more costly at index admission in the UK National Health Service (MD 1190 GBP more, 95% CI 420 GBP to 1970 GBP, 2 studies, 492 participants; low-certainty evidence). AUTHORS\u27 CONCLUSIONS: The evidence was of very low to moderate certainty. Sample sizes were small and underpowered to demonstrate differences in some outcomes. Clinical heterogeneity was also noted. Considering these limitations, there may be little to no effect on mortality. Differences in extracorporeal support times are uncertain, comparing upper hemi-sternotomy to full sternotomy for aortic valve replacement. Before widespread adoption of the minimally invasive approach can be recommended, there is a need for a well-designed and adequately powered prospective randomised controlled trial. Such a study would benefit from also performing a robust cost analysis. Growing patient preference for minimally invasive techniques merits thorough quality of life analyses to be included as end points, as well as quantitative measures of physiological reserve

Long-term survival and freedom from reintervention after off-pump coronary artery bypass grafting: A propensity-matched study.

Background The long term outcomes following off-pump coronary artery bypass grafting (CABG) are the subject of speculation. Our institution has over 15 years of experience performing CABG both off-pump (OPCAB) and on cardiopulmonary bypass (CPB). Our null hypothesis was that there would be no difference in a long-term composite of death and revascularisation between the two methods. Methods We performed a retrospective cohort study of all isolated CABG at our institution from 2001 - 2015. We used an intention to treat analysis, performing risk-adjustment using adjustment for and matching to propensity score. In total, 13226 patients had CABG: 5,882 had OPCAB and 7,344 had CPB with a median follow-up of 6.2 years. Results Of the 5,882 OPCAB, 76 (1.3%) converted to CPB. One, five and ten year survivals in each group were similar (OPCAB vs CPB: 96.7%, 87.9%, 72.1% vs 96.2%, 87.4%, 72.8%). There was no difference in long-term survival (adjusted hazards ratio [HR] 1.03; 95%CI: 0.94, 1.11 for OPCAB vs CPB; p=0.56) or freedom from death and re-intervention (HR 0.98; 95% CI: 0.92 – 1.06 for OPCAB vs CPB; p=0.23). Patients receiving OPCAB had higher EuroSCOREs (median [quartiles]: 2.81 [1.53-5.57] vs 2.73 [1.51-5.22], p=0.01), fewer grafts (mean ± SD: 3.0 ± 0.9 vs 3.3 ± 0.9, p&lt;0.001) but more total arterial grafting (45.9% v 8.4%, p&lt;0.001). OPCAB also had more trainee 1st operators (15.3% v 12.5%), lower cardiac enzyme rise, shorter length of stay and fewer complications (such as MI). Conclusions Off-pump coronary artery bypass grafting is associated with similar long term outcomes to CABG performed on cardiopulmonary bypass in our institution. Our low conversion rate to cardiopulmonary bypass, whilst training junior surgeons, demonstrates that OPCAB can be taught safely. The number of grafts performed between the two approaches is clinically comparable, if statistically different, and appears to provide equal benefits to survival and freedom from re-intervention as on-pump CABG.</p

Long-term survival and freedom from reintervention after off-pump coronary artery bypass grafting: A propensity-matched study.

Background The long term outcomes following off-pump coronary artery bypass grafting (CABG) are the subject of speculation. Our institution has over 15 years of experience performing CABG both off-pump (OPCAB) and on cardiopulmonary bypass (CPB). Our null hypothesis was that there would be no difference in a long-term composite of death and revascularisation between the two methods. Methods We performed a retrospective cohort study of all isolated CABG at our institution from 2001 - 2015. We used an intention to treat analysis, performing risk-adjustment using adjustment for and matching to propensity score. In total, 13226 patients had CABG: 5,882 had OPCAB and 7,344 had CPB with a median follow-up of 6.2 years. Results Of the 5,882 OPCAB, 76 (1.3%) converted to CPB. One, five and ten year survivals in each group were similar (OPCAB vs CPB: 96.7%, 87.9%, 72.1% vs 96.2%, 87.4%, 72.8%). There was no difference in long-term survival (adjusted hazards ratio [HR] 1.03; 95%CI: 0.94, 1.11 for OPCAB vs CPB; p=0.56) or freedom from death and re-intervention (HR 0.98; 95% CI: 0.92 – 1.06 for OPCAB vs CPB; p=0.23). Patients receiving OPCAB had higher EuroSCOREs (median [quartiles]: 2.81 [1.53-5.57] vs 2.73 [1.51-5.22], p=0.01), fewer grafts (mean ± SD: 3.0 ± 0.9 vs 3.3 ± 0.9, p Conclusions Off-pump coronary artery bypass grafting is associated with similar long term outcomes to CABG performed on cardiopulmonary bypass in our institution. Our low conversion rate to cardiopulmonary bypass, whilst training junior surgeons, demonstrates that OPCAB can be taught safely. The number of grafts performed between the two approaches is clinically comparable, if statistically different, and appears to provide equal benefits to survival and freedom from re-intervention as on-pump CABG.</p